Benzeneacetaldehyde, cyclic acetal with glycerol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16-03-2016 to 15-04-2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

Adopted on 26 July 2013

GLP compliance:

yes (incl. QA statement)

Remarks:

Triskelion, Utrechtseweg 48, 3700 AV, Zeist

Test material

Test material information

1

Reference substance name:

Benzeneacetaldehyde, cyclic acetal with glycerol

EC Number:

249-934-2

EC Name:

Benzeneacetaldehyde, cyclic acetal with glycerol

Cas Number:

29895-73-6

Molecular formula:

C11H14O3

IUPAC Name:

Reaction mass of cis-2-benzyl-1,3-dioxan-5-ol and rel-[(2R,4R)-2-benzyl-1,3-dioxolan-4-yl]methanol and rel-[(2R,4S)-2-benzyl-1,3-dioxolan-4-yl]methanol and trans-2-benzyl-1,3-dioxan-5-ol

Test material form:

liquid

Test animals / tissue source

Species:

other: eyes of male or female chickens (ROSS, spring chickens)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Slaughterhouse v.d. Bor, Nijkerkerveen, The Netherlands
- Age at study initiation: approximately 7 weeks
- Weight at study initiation: approximately 1.5 - 2.5 kg
- Heads of the animals were cut off immediately after sedation of the animals by electric shock and incision of the neck for bleeding, and before they reached the next station on the process line. The heads were placed in small plastic boxes on a bedding of paper tissues moistened with isotonic saline. Next, they were transported to the testing facility. During transportation, the heads were kept at ambient temperature.
- The preparation and validation of the eyes prior to the ICE-test were all according to OECD guideline 438.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Positive controls: Benzalkonium Chloride. Negative control: Physiological saline.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 30 µL

Duration of treatment / exposure:

10 seconds

Duration of post- treatment incubation (in vitro):

240 minutes

Number of animals or in vitro replicates:

3 eyes

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The eyes were rinsed with 20 mL saline
- Time after start of exposure: 10 seconds

SCORING SYSTEM: According to OECD 438 guideline. Examination of the eyes after 0, 30, 75, 120, 180, and 240 minutes

TOOL USED TO ASSESS SCORE: All examinations were carried out with the slit lamp microscope. Fluorescein retention was only scored at approximately 30 minutes after treatment.

CONTROLS: A negative control (30 µL physiological saline) and 3 positive controls (30 µL Benzalkonium Chloride 5%) were included.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

percent corneal swelling

Run / experiment:

Slit-lamp examination

Value:

13

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Maximum mean score

Results 2

Irritation parameter:

cornea opacity score

Run / experiment:

Slit-lamp examination

Value:

2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Maximum mean score

Results 3

Irritation parameter:

fluorescein retention score

Run / experiment:

Slit-lamp examination

Value:

2.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

Slit-lamp examination: The test substance caused corneal effects consisting of slight corneal swelling (mean of 13%), moderate opacity (mean score of 2.0) and moderate-to-severe fluorescein retention (mean score of 2.5). In addition, loosening (veil-like) of epithelium was observed in one cornea. The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control BAC 5% caused moderate or severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants.

Microscopic examination: Microscopic examination of the corneas treated with the test substance revealed very slight or slight erosion (two corneas), moderate necrosis (two corneas) and moderate vacuolation of the epithelium. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities. Microscopic examination of the corneas treated with the positive control BAC 5% revealed slight erosion and very slight or slight vacuolation of the epithelium, the epithelium partly detached from the basement membrane, and endothelial necrosis (two corneas).

Any other information on results incl. tables

In order to translate the eye irritancy scores from the ICE test to an EU-CLP regulatory classification, four irritancy classes from the ICE study need to be reconciled into three classes within the EU-CLP regulatory classification scheme. This was achieved through application of the prediction model defined in Annex 1 of the study report which is based on scientific judgment and which is supported by several years of experience with conduct of the ICE test. This has resulted in 3 classes of the EU CLP: non eye irritant; serious eye irritation and causes serious eye damage. Despite the serious eye irritation class not considered fully validated in the OECD TG guideline, the categorisation as outlined in the report serious eye irritation is sufficiently scientifically valid, the substance is in the applicability domain of the method and the result is adequately and reliably documented.

Applicant's summary and conclusion

Interpretation of results:

other: Irritating to eyes, Cat 2

Remarks:

according to EU CLP (1272/2008 and its amendments)

Conclusions:

Under the test conditions (OECD 438) the substance has to be classified as Cat. 2 and 2A in accordance with EU CLP and GHS, respectively.

Executive summary:

In accordance to OECD guideline 438 and GLP the test substance was examined for its in vitro eye irritating potential using the Isolated Chicken Eye (ICE) Test. In the ICE test, 3 eyes were exposed to 30 µL test substance for 10 seconds. In addition, one negative control eye (30 µL saline) and three positive control eyes (30 µL Benzalkonium Chloride (BAC)) were tested. After the exposure the eyes were rinsed with 20 mL saline and were examined at approximately 0, 30, 75, 120, 180, and 240 minutes after treatment. The test substance caused corneal effects consisting of slight corneal swelling (mean of 13%), moderate opacity (mean score of 2.0) and moderate-to-severe fluorescein retention (mean score of 2.5). In addition, loosening (veil-like) of epithelium was observed in one cornea. The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control BAC 5% caused moderate or severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants. Microscopic examination of the corneas treated with the test substance revealed very slight or slight erosion (two corneas), moderate necrosis (two corneas) and moderate vacuolation of the epithelium. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities. Microscopic examination of the corneas treated with the positive control BAC 5% revealed slight erosion and very slight or slight vacuolation of the epithelium, the epithelium partly detached from the basement membrane, and endothelial necrosis (two corneas). Based on these results, the substance is considered an eye irritant.